Pseudomonas aeruginosa and Acinetobacter baumannii PCR Kit CE/IVD

1 Intended use:
RealCycler PACI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Pseudomonas aeruginosa and Acinetobacter baumannii simultaneously in clinical samples.
The system includes an internal control CHIC (Competitive Heterologous Internal Control) to prevent false negatives due to reaction inhibition.

2 Principle of the test
The polymerase chain reaction (PCR) is based on the amplification of a specific region of the DNA/RNA by using complementary primers to the target sequence. Real-time PCR uses marked probes with fluorophores that emit fluorescence in the case of amplification. The cycle of the PCR protocol in which appears significant fluorescence is proportional to the DNA/RNA quantity present in the sample. This value is called Cycle Threshold (Ct) or Cycle Quantification (Cq).
The amplification of Pseudomonas aeruginosa is detected in FAM, Acinetobacter baumannii in TxR and the internal control in Alx532.

3 Technical specifications
Sensitivity
- 100 copies/μL for Pseudomonas aeruginosa and
- 10 copies/μL for Acinetobacter baumannii
Specificity
- Pseudomonas aeruginosa (hcpC gene) and
- Acinetobacter baumannii (dnaA gene).

4 Contents
RealCycler PACI includes the AmpliMix and a PACI DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa and Acinetobacter baumannii DNA.
All All reagents are ready to use without adding or rebuilding any component.